TREANDA (bendamustine hydrochloride - solution;iv (infusion))

Has a generic version of Treanda been approved?

No. There is currently no therapeutically equivalent version of Treanda available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Treanda. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)

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Drug product

March 23, 2030

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Pediatric exclusivity

Bendamustine pharmaceutical compositionsPatent 8,436,190Issued: May 7, 2013Assignee(s): Cephalon, Inc.The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.

Patent expiration dates:

October 26, 2030

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Drug product

April 26, 2031

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Pediatric exclusivity

Solid forms of bendamustine hydrochloridePatent 8,445,524Issued: May 21, 2013Assignee(s): Cephalon, Inc.Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.

Patent expiration dates:

March 26, 2029

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Drug substance

March 26, 2029

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Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)

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Drug substance

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Drug product

September 26, 2029

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Pediatric exclusivity

Bendamustine pharmaceutical compositionsPatent 8,609,863Issued: December 17, 2013Assignee(s): Cephalon, Inc.The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.

Patent expiration dates:

January 12, 2026

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Drug product

July 12, 2026

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Pediatric exclusivity

Solid forms of bendamustine hydrochloridePatent 8,669,279Issued: March 11, 2014Assignee(s): Cephalon, Inc.Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.

Patent expiration dates:

March 26, 2029

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Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)

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Drug product

September 26, 2029

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Pediatric exclusivity

Bendamustine pharmaceutical compositionsPatent 8,791,270Issued: July 29, 2014Assignee(s): Cephalon, Inc.The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.

Patent expiration dates:

January 12, 2026

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Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA

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Drug product

July 12, 2026

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Pediatric exclusivity

Solid forms of bendamustine hydrochloridePatent 8,883,836Issued: November 11, 2014Assignee(s): Cephalon, Inc.Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.

Patent expiration dates:

March 26, 2029

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Patent use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)

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Drug product

September 26, 2029

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Pediatric exclusivity

Bendamustine pharmaceutical compositionsPatent 8,895,756Issued: November 25, 2014Assignee(s): Cephalon, Inc.The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.

Patent expiration dates:

January 12, 2026

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Drug product

July 12, 2026

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Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Glossary

Term

Definition

Drug Patent

A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.

Drug Exclusivity

Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.

RLD

A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

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